List of exempted medical devices published by the MHRA
The UK MHRA has published a list of medical devices that are accessible for use without CE marking. Typically, all Medical Devices are required to have a CE mark in order to be placed in the European market unless:
It is a custom-made device;
It is an investigational device;
The device is derogated from CE-marking if the device is required for a single patient (patient specific), or if there’s a health risk if the device is not obtainable;
If the device taken into consideration follows one of the above conditions, it is exempted and can therefore be made available to healthcare providers and patients.
Article 59 of the MDR, which covers the Member States exempting medical devices from CE marking, has been changed in order to expand the use of such devices in other markets once it has been exempted in one Member State. The MDR implementation has been postponed to May 2021, while the implementation of Article 59 has been moved to April 24th 2020 to allow for a better response of the medical needs arose from the covid-19 pandemic.
The UK is the only Member State that has prepared a derogation procedure with a list of over 50 devices/device families that can be used without having the CE mark. It is expected that other Member States will soon generate similar lists to help their citizens to verify whether a device can be used without CE marking.